Therapie最新文献

{"title":"COVACPREG, a French prospective cohort study of women vaccinated against COVID-19 during pregnancy","authors":"Isabelle Lacroix ,&nbsp;Anthony Caillet ,&nbsp;Laurane Delteil ,&nbsp;Hadjer Ameur ,&nbsp;Nassima Padelli ,&nbsp;Caroline Hurault-Delarue ,&nbsp;Judith Cottin","doi":"10.1016/j.therap.2024.06.003","DOIUrl":"10.1016/j.therap.2024.06.003","url":null,"abstract":"<div><div><span><span>The objective of this cohort study was to describe the French population of pregnant women vaccinated against coronavirus disease 2019 (COVID-19), their pregnancy outcomes and the </span>health status<span><span> of their newborns (malformation rate, neonatal diseases, etc.), and to proactively collect and analyze reported </span>adverse reactions over time. We conducted a prospective study using an online questionnaire. Women vaccinated during pregnancy who wanted to participate were asked to complete an inclusion questionnaire (dates of pregnancy and </span></span>vaccination<span> COVID-19, etc.), a questionnaire on the potential occurrence of adverse reactions (time of onset, type of adverse reaction, etc.) of the vaccination, sent 1 month after the injection, and a final questionnaire on the outcome of the pregnancy and the health status of the child. A total of 938 women were prospectively included in this first French study. A total of 132 women reported having had at least 1 adverse reaction following vaccination during pregnancy (14.1%), including few ‘serious’ adverse reaction (5.3%). There were no signals of adverse reactions during continuous monitoring. Among the 938 pregnant women, 22.4% received the vaccination COVID-19 during the first trimester, 64.2% during the second and 33.4% during the third trimester (some women have had several injections in different trimesters). Among the 938 women, 4.3% developed gestational hypertension<span><span> and 13.9% diabetes; 3.3% had intrauterine growth restriction and 7.8% threatened </span>preterm delivery. These rates are comparable to those observed in the French general population. Among live births, the rate of preterm birth was 5.1%. We reported a prevalence of major malformations of 3.9%, which is comparable to that reported by European Surveillance of Congenital Anomalies (EUROCAT), with a rate of 3.5% of major malformations in the general population of mainland France. In conclusion, our study did not demonstrate any particular safety signals in the event of vaccination with a Covid-19 vaccine during pregnancy.</span></span></div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 271-278"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141601799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Elexacaftor/tezacaftor/ivacaftor induced liver enzymes abnormalities in breastfed infants: A series of 3 cases","authors":"Sandrine Bergeron ,&nbsp;Camille Audousset ,&nbsp;Gurvan Bourdon ,&nbsp;Charles Garabedian ,&nbsp;Sophie Gautier","doi":"10.1016/j.therap.2024.08.001","DOIUrl":"10.1016/j.therap.2024.08.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 341-343"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142296166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hépatite aiguë cytolytique suivie d’œdèmes associés à l’utilisation des neuroleptiques : à propos d’un cas et revue de la littérature","authors":"Fatma Guermazi ,&nbsp;Rabeb Jbir ,&nbsp;Imen Bouaziz ,&nbsp;Rim Atheymen ,&nbsp;Dorra Mnif ,&nbsp;Nourelhouda Ben Ali ,&nbsp;Kamilia Ksouda ,&nbsp;Khaled Zghal ,&nbsp;Imen Baati ,&nbsp;Jawaher Masmoudi","doi":"10.1016/j.therap.2024.11.004","DOIUrl":"10.1016/j.therap.2024.11.004","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 348-351"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effets indésirables de l’association tezacaftor/ivacaftor/elexacaftor pouvant mener à un arrêt de traitement : à propos d’une série de 10 cas","authors":"Elora Blaisonneau ,&nbsp;Brendan Le Daré ,&nbsp;Marion Mercerolle ,&nbsp;Astrid Bacle ,&nbsp;Louise Triquet ,&nbsp;Marie-Noëlle Osmont ,&nbsp;Chantal Belleguic ,&nbsp;Elisabeth Polard","doi":"10.1016/j.therap.2024.06.005","DOIUrl":"10.1016/j.therap.2024.06.005","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;Les modulateurs des canaux &lt;em&gt;cystic fibrosis transmembrane regulator&lt;/em&gt; (CFTR) (ivacaftor, lumacaftor, tezacaftor et elexacaftor) constituent une avancée majeure dans la prise en charge de la mucoviscidose. Cependant, peu de données existent quant au profil de sécurité de ces médicaments en vie réelle, en particulier sur les effets indésirables pouvant conduire à leur arrêt. L’objectif de cette étude est de décrire les caractéristiques et l’évolution des effets indésirables de l’association tezacaftor/ivacaftor/elexacaftor ayant mené à un arrêt et rapportés au Centre régional de pharmacovigilance (CRPV) de Rennes (France).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Matériels et méthodes&lt;/h3&gt;&lt;div&gt;Une étude rétrospective a été menée de décembre 2021 à mai 2023, portant sur les cas d’arrêt de l’association tezacaftor/ivacaftor/elexacaftor en raison de la survenue d’un ou plusieurs effets indésirables, cas rapportés au CRPV de Rennes (France).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;Dix cas d’arrêt de médicament ont été rapportés au CPRV de Rennes (6 femmes/4 hommes). Les effets indésirables concernaient majoritairement les troubles neuropsychiatriques (&lt;em&gt;n&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;6), suivis des perturbations du bilan hépatique (&lt;em&gt;n&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;2), des troubles otorhinolaryngologiques (ORL) (&lt;em&gt;n&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;1) et des troubles digestifs (&lt;em&gt;n&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;1). La durée moyenne de traitement à l’arrêt était de 339,8 [39–668] jours. Le médicament a été réintroduit chez 7 patients en moyenne 48,7 [7–123] jours après l’arrêt, avec une adaptation de posologie (&lt;em&gt;n&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;4) consistant en une inversion des moments de prise ou une diminution des doses journalières, avec ou sans succès sur la symptomatologie des effets indésirables en fonction des cas.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;Cette petite série de cas suggère que les effets indésirables neuropsychiatriques pourraient survenir plus fréquemment qu’initialement décrit après l’instauration de tezacaftor/ivacaftor/elexacaftor, et devraient faire l’objet d’un dépistage et d’un suivi attentifs. Des modifications de la posologie ou du rythme d’administration peuvent être envisagées pour les patients souffrant de ces effets indésirables. De plus amples études de pharmacovigilance seraient nécessaires pour mieux connaître les profils d’effets indésirables des « caftors », leurs éventuels facteurs de risque d’apparition et l’impact de l’adaptation des modalités de prise.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;Cystic fibrosis transmembrane regulator (CFTR) channel modulators (ivacaftor, lumacaftor, tezacaftor and elexacaftor) represent a major advance in the management of cystic fibrosis. However, few data are available on the real-life safety profile of these medications, in particular on adverse events that may lead to their discontinuation. The aim of this study is to describe the characteristics and evolution of adverse reactions to the t","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 279-293"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141690204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retinal vascular occlusion after COVID-19 vaccination: Analysis of the French pharmacovigilance database","authors":"Mathilde Beurrier ,&nbsp;Jean-Bapiste Conart ,&nbsp;Marie Lauren Antoine ,&nbsp;Anthony Facile ,&nbsp;Haleh Bagheri ,&nbsp;Valérie Gras-Champel ,&nbsp;Nadine Petitpain","doi":"10.1016/j.therap.2024.08.002","DOIUrl":"10.1016/j.therap.2024.08.002","url":null,"abstract":"<div><div>Retinal vein occlusions and central retinal artery occlusions have been reported with coronavirus disease 2019 (COVID-19) vaccines. We aim to provide a descriptive analysis of cases reported in France until mid-2023, and recorded in the French pharmacovigilance database. An independent ophthalmologist reviewed all cases. We analyzed 290 cases (228 retinal vein occlusions, 58 central retinal artery occlusions, and four combinations). Retinal vein occlusions occurred with mRNA vaccines (68.0%) and adenovirus-vectored vaccines (32%), with an 11-day median onset delay. Almost half of the patients had retinal vein occlusion risk factors, mainly hypertension, and five had a positive rechallenge. Considering the lower adenovirus-vectored vaccines exposure in France, their proportion of retinal vein occlusions appears high. Among the 58 central retinal artery occlusion cases, most occurred with mRNA vaccines in patients with retinal artery occlusion risk factors (mainly hypertension), with a 17-day median onset delay. In conclusion, there was a temporal association in almost half of cases, but few cases with positive rechallenge, and many cases were confounded by risk factors (e.g., cardiovascular disorders, diabetes), which are also COVID-19 risk factors. Therefore, the risk of retinal vascular occlusion does not challenge the benefit-risk ratio of the vaccination, especially for mRNA vaccines.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 295-303"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142296167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adalimumab-induced myoclonus: A potential adverse drug reaction?","authors":"Yasmine Salem Mahjoubi ,&nbsp;Israa Dahmani ,&nbsp;Fatma Zgolli ,&nbsp;Widd Kaabi ,&nbsp;Sarrah Kastalli ,&nbsp;Imen Aouintin ,&nbsp;Sihem El Aidli","doi":"10.1016/j.therap.2024.12.006","DOIUrl":"10.1016/j.therap.2024.12.006","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 356-358"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adagrasib-induced photodistributed hyperpigmentation: Two case reports and pathogenetic hypothesis","authors":"Julien Lebled ,&nbsp;Jean-Paul Claudel ,&nbsp;Marie-Sarah Agier ,&nbsp;Laurent Plantier ,&nbsp;Bérenger Largeau ,&nbsp;Annie-Pierre Jonville-Bera","doi":"10.1016/j.therap.2024.12.014","DOIUrl":"10.1016/j.therap.2024.12.014","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 333-336"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Évaluation des dépenses du circuit des produits de santé dans le cadre d’études institutionnelles – Étude de cas au CHU de Toulouse","authors":"Marie Delon,&nbsp;Pierjan Fourniols,&nbsp;Anabel Saint-Pastou,&nbsp;Geoffrey Bourcier,&nbsp;Audrey Tranier,&nbsp;Laetitia Caturla,&nbsp;Camille Jurado","doi":"10.1016/j.therap.2024.06.001","DOIUrl":"10.1016/j.therap.2024.06.001","url":null,"abstract":"&lt;div&gt;&lt;div&gt;La recherche clinique institutionnelle est essentielle mais confrontée à des défis budgétaires imprévus notamment quand elle est centrée sur les produits de santé. Cette étude rétrospective analyse les devis et coûts réels de 13 études gérées par la pharmacie coordinatrice des essais cliniques du CHU de Toulouse. Elle vise à évaluer la précision des devis, identifier les événements impactant les essais cliniques et rechercher des variables d’ajustements budgétaires. Les résultats montrent que seulement deux des 13 études respectent leur devis initial, la plupart dépassant les marges prévues. Les coûts varient par secteur, avec des dépenses dépassant souvent le budget initial pour les envois et les conditionnements, tandis que les coûts liés à la distribution sont plus précis. Plusieurs facteurs influencent les coûts, notamment la durée de l’étude, la localisation des centres, le nombre d’inclusions, la stabilité du produit et les modifications du protocole. L’augmentation de la durée de l’étude entraîne des dépenses accrues dans tous les secteurs, tandis que la diminution du nombre d’inclusions tend à respecter le budget initial. En conclusion, la gestion budgétaire des essais cliniques est complexe en raison de nombreuses variables influentes. Une planification rigoureuse et la prise en compte des particularités de chaque étude sont essentielles pour des devis plus précis et le respect des budgets. Cette étude contribue à mieux comprendre les défis financiers des promoteurs institutionnels d’essais cliniques et à améliorer les méthodes de budgétisation pour les futures études cliniques.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;Clinical research faces complex and unpredictable budgetary challenges, despite its central role in the development of healthcare products. This retrospective study examines the estimated and actual costs of 13 trials managed by the Clinical Trials Coordinating Pharmacy at the University Hospital of Toulouse. It aims to assess the accuracy of estimates, identify trial-influencing events and identify budget adjustment variables. The results show that only two of the 13 studies stay within their initial estimates, with most exceeding their projected margins. Costs vary by area, with shipping and packaging in particular exceeding the initial budget, while distribution costs are more accurately estimated. Several factors influence costs, including study duration, centre locations, number of enrolments, product stability and protocol amendments. Extending the study duration leads to increased costs in all areas, while reducing the number of inclusions tends to be in line with the original budget. In conclusion, budget management in clinical trials is complex due to numerous influencing variables. Careful planning and consideration of the specifics of each trial are crucial for more accurate estimates and budget adherence. This study enhances the understanding of the financial challenges faced by institutional sponsors of clinical trials ","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 259-269"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141407332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Voxelotor-induced pulmonary embolism","authors":"Pauline Schiro ,&nbsp;Romain Barus ,&nbsp;Laurent Chouchana ,&nbsp;Rayane Sari ,&nbsp;Pierre Cougoul ,&nbsp;François Montastruc ,&nbsp;Haleh Bagheri","doi":"10.1016/j.therap.2024.10.050","DOIUrl":"10.1016/j.therap.2024.10.050","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 343-346"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142558864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oxybutynin induced blindness in a child: Case report","authors":"Mouna Daldoul ,&nbsp;Ahmed Zaiem ,&nbsp;Yasmine Salem Mahjoubi ,&nbsp;Ons Charfi ,&nbsp;Ghozlane Lakhoua ,&nbsp;Sarrah Kastalli ,&nbsp;Riadh Daghfous ,&nbsp;Imen Aouinti ,&nbsp;Sihem El Aidli","doi":"10.1016/j.therap.2024.11.003","DOIUrl":"10.1016/j.therap.2024.11.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 346-348"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}